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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Dankook University | OTHER |
| International Tuberculosis Research Center | OTHER |
| Pusan National University Yangsan Hospital |
Not provided
Not provided
Not provided
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The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24 months (control arm)' for treating fluoroquinolone-sensitive multidrug-resistant tuberculosis.
This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20-24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after treatment initiation. Secondary outcomes include time to sputum culture conversion on liquid and solid media, proportions of sputum culture conversion on liquid media after 2 and 6 months of treatment, treatment success rate according to pyrazinamide resistance, and occurrence of adverse events grade 3 and above as evaluated by the Common Terminology Criteria for Adverse Events. The population number is calculated as 102 per group (204 in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
|
|
| Experimental Arm | Experimental | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug |
| ||
| Delamanid |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Rate | To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results) | 24 months after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sputum Culture Conversion After Treatment Start | To determine whether time to sputum culture conversion after treatment start is statistically different between the control and investigational arms, the median time will be estimated in each group using the Kaplan-Meier method, and the difference in the distribution of time to culture conversion of the two arms will be compared using the log-rank test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36522208 | Derived | Mok J, Lee M, Kim DK, Kim JS, Jhun BW, Jo KW, Jeon D, Lee T, Lee JY, Park JS, Lee SH, Kang YA, Lee JK, Kwak N, Ahn JH, Shim TS, Kim SY, Kim S, Kim K, Seok KH, Yoon S, Kim YR, Kim J, Yim D, Hahn S, Cho SN, Yim JJ; MDR-END investigators. 9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): a multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea. Lancet. 2022 Oct 29;400(10362):1522-1530. doi: 10.1016/S0140-6736(22)01883-9. | |
| 30651149 |
Not provided
Not provided
Of the 443 eligible patients, 229 were excluded for the following reasons:
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
Locally-used WHO-approved MDR-TB regimen in Korea |
| FG001 | Experimental Arm | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
Linezolid Delamanid Levofloxacin Pyrazinamide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
mITT population of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
Locally-used WHO-approved MDR-TB regimen in Korea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Success Rate | To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results) | mITT population Participant with [not assessable] was not included in the analysis | Posted | Count of Participants | Participants | 24 months after treatment start |
|
All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
Locally-used WHO-approved MDR-TB regimen in Korea |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prof. JJ Yim | Seoul National University | 82-02-1588-5700 | yimjj@snu.ac.kr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2020 | Nov 7, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069349 | Linezolid |
| C516022 | OPC-67683 |
| D064704 | Levofloxacin |
| D011718 | Pyrazinamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
| OTHER |
| Pusan National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Severance Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Incheon St.Mary's Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Korean Institute of Tuberculosis | OTHER |
| National Medical Center, Seoul | OTHER |
| Korean Center for Disease Control and Prevention | OTHER_GOV |
| Korea University Ansan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Levofloxacin | Drug |
|
| Pyrazinamide | Drug |
|
| Locally-used WHO-approved MDR-TB regimen in Korea | Drug |
|
| through study completion (24 months after treatment start) |
| Sputum Culture Conversion Proportion | Culture conversion rate at month 2 of treatment in participants with positive baseline sputum culture (liquid media). | At 2 months of treatment |
| Treatment Success at the End of Treatment | Treatment success rate at the end of treatment.
| At the end of treatment |
| Proportion of Reverting to Positive Sputum Culture After the End of Treatment | The proportion of patients who experienced a reversion between the end of treatment and up to 24 months after treatment start | At 24months after treatment start |
| Treatment Success According to Pyrazinamide Resistance (1) | Treatment success rate of participants with pyrazinamide resistance in the mITT analysis | At 24months after treatment start |
| Proportion of Death Between the Control and Investigational Arms | The proportion of participants who died in the control and experimental arm mITT population | At 24months after treatment start |
| Sputum Culture Conversion Proportion | Culture conversion rate at month 6 of treatment in participants with positive baseline sputum culture (liquid media). | At 6 months of treatment start |
| Treatment Success According to Pyrazinamide Resistance (2) | Treatment success rate of participants without pyrazinamide resistance in the mITT analysis | At 24 months after treatment start |
| Derived |
| Lee M, Mok J, Kim DK, Shim TS, Koh WJ, Jeon D, Lee T, Lee SH, Kim JS, Park JS, Lee JY, Kim SY, Lee JH, Jo KW, Jhun BW, Kang YA, Ahn JH, Kim CK, Shin S, Song T, Shin SJ, Kim YR, Ahn H, Hahn S, Won HJ, Jang JY, Cho SN, Yim JJ. Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial. Trials. 2019 Jan 16;20(1):57. doi: 10.1186/s13063-018-3053-1. |
| BG001 |
| Experimental Arm |
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
Linezolid Delamanid Levofloxacin Pyrazinamide |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Characteristics of Participants | Count of Participants | Participants |
|
| OG001 | Experimental Arm | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
Linezolid Delamanid Levofloxacin Pyrazinamide |
|
|
| Secondary | Time to Sputum Culture Conversion After Treatment Start | To determine whether time to sputum culture conversion after treatment start is statistically different between the control and investigational arms, the median time will be estimated in each group using the Kaplan-Meier method, and the difference in the distribution of time to culture conversion of the two arms will be compared using the log-rank test. | Participants with a positive baseline M.tuberculosis culture (liquid media) in the mITT population | Posted | Median | Inter-Quartile Range | day | through study completion (24 months after treatment start) |
|
|
|
| Secondary | Sputum Culture Conversion Proportion | Culture conversion rate at month 2 of treatment in participants with positive baseline sputum culture (liquid media). | mITT population Participants with positive baseline sputum culture | Posted | Count of Participants | Participants | At 2 months of treatment |
|
|
|
| Secondary | Treatment Success at the End of Treatment | Treatment success rate at the end of treatment.
| mITT populration One participant of experimental arm who became pregnant during the treatment was excluded | Posted | Count of Participants | Participants | At the end of treatment |
|
|
|
| Secondary | Proportion of Reverting to Positive Sputum Culture After the End of Treatment | The proportion of patients who experienced a reversion between the end of treatment and up to 24 months after treatment start | mITT population Participant with [not assessable] was not included in the analysis | Posted | Count of Participants | Participants | At 24months after treatment start |
|
|
|
| Secondary | Treatment Success According to Pyrazinamide Resistance (1) | Treatment success rate of participants with pyrazinamide resistance in the mITT analysis | mITT population Participant with [not assessable] was not included in the analysis | Posted | Count of Participants | Participants | At 24months after treatment start |
|
|
|
| Secondary | Proportion of Death Between the Control and Investigational Arms | The proportion of participants who died in the control and experimental arm mITT population | mITT population | Posted | Count of Participants | Participants | At 24months after treatment start |
|
|
|
| Secondary | Sputum Culture Conversion Proportion | Culture conversion rate at month 6 of treatment in participants with positive baseline sputum culture (liquid media). | mITT population participants with positive baseline sputum culture (liquid media) | Posted | Count of Participants | Participants | At 6 months of treatment start |
|
|
|
| Secondary | Treatment Success According to Pyrazinamide Resistance (2) | Treatment success rate of participants without pyrazinamide resistance in the mITT analysis | mITT population Participant with [not assessable] was not included in the analysis | Posted | Count of Participants | Participants | At 24 months after treatment start |
|
|
|
| 2 |
| 89 |
| 19 |
| 89 |
| 87 |
| 89 |
| EG001 | Experimental Arm | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
Linezolid Delamanid Levofloxacin Pyrazinamide | 5 | 79 | 20 | 79 | 78 | 79 |
| Cytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | Systematic Assessment |
|
| Meningitis cryptococcal | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Epidural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Poisoning deliberate | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | Systematic Assessment |
|
| Hepatitis B DNA increased | Investigations | Systematic Assessment |
|
| Liver function test abnormal | Investigations | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | Systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ligament operation | Surgical and medical procedures | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Glare | Eye disorders | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Optic nerve disorder | Eye disorders | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
|
| Visual impairment | Eye disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal tract irritation | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oral mucosa erosion | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Condition aggravated | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Feeling hot | General disorders | Systematic Assessment |
|
| Generalised oedema | General disorders | Systematic Assessment |
|
| Granuloma | General disorders | Systematic Assessment |
|
| Localised oedema | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Systematic Assessment |
|
| Dermatophytosis of nail | Infections and infestations | Systematic Assessment |
|
| Folliculitis | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Otitis media | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Rash pustular | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Blood uric acid increased | Investigations | Systematic Assessment |
|
| Colour vision tests abnormal | Investigations | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
|
| Hepatic enzyme abnormal | Investigations | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
| Liver function test abnormal | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Dementia | Nervous system disorders | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Delusion | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Major depression | Psychiatric disorders | Systematic Assessment |
|
| Obsessive thoughts | Psychiatric disorders | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Flushing | Vascular disorders | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011719 | Pyrazines |